MAUDE Adverse Event Report: RESPIRONICS INC. BIPAP AUTOSV; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DS960S

Device Problem Degraded (1153)

Patient Problems Burning Sensation (2146); Sore Throat (2396); Respiratory Tract Infection (2420); Nasal Obstruction (2466)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.The pateint alleged nasal or throat irritation.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported incorrect information in section b4.The manufacturer previously reported in section b4 incorrect date which is reported correctly in b4 section.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to a bilevel positive airway pressure (bipap) device's sound abatement foam become degraded and cause the patient's sore throat or nasal irritation.There was no report of patient any serious harm or injury.In initial and first follow up report b4 dates in both scenarios were incorrect.The correct date should have been 06/06/2022, and follow up 06/09/2022, respectively.In section b5 additional report has been added that the patient also alleged having 'particles in device and burning sensation'.In previous report, in section h6 health effect - clinical code for burning sensation and nasal irritation was not added and 2466 was incorrectly added which has been corrected / updated in this report.

Manufacturer Narrative

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging burning sensation in airways, particles in device, device was noisy, burning/smoke/electrical odor and nasal/throat irritation or soreness related to a bipap device's sound abatement foam.There was no report of patient harm or injury.After the final attempt to have the device and components returned for evaluation, customer declined to respond to the gfe related questions and terminated the call.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: BIPAP AUTOSV
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS INC.; 1001 murry ridge ln; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 14606317
• MDR Text Key: 300787918
• Report Number: 2518422-2022-30035
• Device Sequence Number: 1
• Product Code: MNS
• UDI-Device Identifier: 00606959012516
• UDI-Public: 00606959012516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DS960S
• Device Catalogue Number: DS960S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1